Lead Medical Device R&D Engineer

Katalyst CRO; Cleveland (OH); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced R&D leader to drive development, characterization, and validation of medical device processes in a fast-paced environment. You'll design and execute DOE, TMV, IQ/OQ/PQ studies, applying rigorous statistics to solve complex problems and improve products.

You will mentor senior and junior engineers and collaborate across cross-functional teams to move projects from research to implementation.

Qualifications

• Advanced degree or equivalent experience in a relevant scientific/engineering field.
• Experience with process development and validation in medical device R&D.
• Strong statistical and problem-solving skills; leadership experience.

Responsibilities

• Lead development, characterization, and validation of medical device processes.
• Design/execute DOE, TMV, IQ/OQ/PQ studies.
• Apply statistical analysis to drive process improvements.
• Mentor team members and coordinate cross-functional projects.
• Support product development from research to implementation.

Skills

Process Development

DOE

Process Characterization

TMV

IQ/OQ/PQ

Statistics

Project Leadership

Education

Advanced degree in Physics/Engineering or related field

Bachelor's degree in a relevant field

Job description

Katalyst CRO is seeking an experienced R&D leader to drive development, characterization, and validation of medical device processes in a fast-paced environment. You'll design and execute DOE, TMV, IQ/OQ/PQ studies, applying rigorous statistics to solve complex problems and improve products.

You will mentor senior and junior engineers and collaborate across cross-functional teams to move projects from research to implementation.